Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children

NCT07154992 | Recruiting

• 1 other identifier: IRESP.PROB-2
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, placebo-controlled, parallel-group, clinical trial to assess the efficacy of the intake of a probiotic product composed of Lacticaseibacillus rhamnosus CRL1505 strain in reducing or preventing upper respiratory tract infections (URTIs) in a healthy paediatric population.

Conditions

Upper Respiratory Tract Infection; Prevention

Keywords

prevention; upper respiratory tract infections; probiotics; microbiota; microbiome; children

Outcome Measures

Primary Outcomes (3)

• Patients who were diagnosed with at least 1, 2 or 3 URTIs

  Difference in the proportion of patients who were diagnosed with at least 1, 2 or 3 URTIs during the intervention (12 weeks) and follow-up period (16 weeks) between the study groups

  12 and 16 weeks

• Number of URTIs per patient

  Difference in the mean number of URTIs per patient between the study groups during the intervention period (12 weeks) and follow-up period (16 weeks)

  12 and 16 weeks

• Patients who were diagnosed of common cold and influenza

  Difference in the proportion of patients who were diagnosed of common cold and influenza during the intervention (12 weeks) and follow-up period (16 weeks) between the study groups. \*This analysis will only be performed if a considerable number of URTIs other than the common cold are recorded.

  12 and 16 weeks

Secondary Outcomes (13)

• Participants who presented URTI complications

  12 and 16 weeks

• Number of days with a URTI episode per participant

  12 and 16 weeks

• Number of days until the first URTI

  12 weeks

• Duration of each URTI episode

  12 and 16 weeks

• URTI-free time rate

  12 and 16 weeks

Other Outcomes (1)

• Incidence and severity of all Adverse Events

  12 and 16 weeks

Study Arms (2)

PROBIOTIC

EXPERIMENTAL

Dietary Supplement: Probiotic - Lacticaseibacillus rhamnosus CRL1505

PLACEBO

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic - Lacticaseibacillus rhamnosus CRL1505 DIETARY_SUPPLEMENT

The probiotic product is provided in 2g sticks containing the strain Lacticaseibacillus rhamnosus CRL1505 at a concentration of ≥ 1.0E+8 CFU/g, with corn starch and maltodextrin as excipients.

PROBIOTIC

Placebo DIETARY_SUPPLEMENT

The placebo product is provided in 2g sticks of corn starch and maltodextrin.

PLACEBO

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 3 to 12 years.
• Signed Informed Consent by the parents

You may not qualify if:

• Chronic pathological conditions, such as chronic respiratory diseases (asthma, chronic bronchitis, etc.), chronic heart diseases, chronic neurological diseases (psychomotor impairment, etc.), chronic liver diseases, chronic kidney diseases, chronic gastrointestinal diseases, hematological disorders, etc., or any other disease or condition that the investigator considers to significantly affect the health of the participating child.
• Metabolic disorders, such as diabetes mellitus, obesity, etc.
• Immunodeficiency, including HIV infection, chronic corticosteroid treatment, etc.
• Nasal polyps, nasal ulcers, or other conditions that may cause nasal obstruction.
• Regular use of medications or dietary supplements that may influence the study outcomes (immunosuppressants/immunostimulants, including echinacea supplements, analgesics, anti-inflammatory drugs, antitussives/expectorants, flu preparations, decongestants, antibiotics, antihistamines, probiotics, etc.) within the 4 weeks prior to the start of the clinical trial.

Sponsors & Collaborators

• Bioithas SL: lead
• Centro Sperimentale del Latte S.r.l.: collaborator

Study Sites (1)

MiBioPath Research Group (UCAM)

Murcia, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Valentina Taverniti

  Microbes & Health R&D Leader, Centro Sperimentale del Latte S.r.l.

  STUDY DIRECTOR

Central Study Contacts

Juan Gabriel Agüera Santos

CONTACT

+34623022586; juan.aguera@bioithas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: December 17, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

ES (1)